HepatoCellular CarcinomaPhase 3NCT02987907
The Impact on Therapeutic Effect and Tolerance of Treatment for Patients With Hepatocellular Carcinoma in Transcatheter Arterial Chemoembolization (TACE) of Dexamethasone Application: A Random, Double-blind, Controlled, Clinical Trial.
A Phase 3 study testing Dexamethasone and Normal Saline in people with HepatoCellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
The current random, double-blind, controlled, clinical trial was designed to evaluate the impact on therapeutic effect and tolerance of treatment for patients with hepatocelluclar carcinoma in transcatheter arterial chemoembolization (TACE) of dexamethasone application. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HepatoCellular Carcinoma
- What is being tested?
- Dexamethasone and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Aug 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 18 years old;
- ECOG PS<3;
- proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
- meeting at least 1/4: 1) multiple nodules, 2) single tumor but not suitable for resection, 3) vascular invasion exists, 4) distant metastasis excluding CNS and bone
- not previous treated for tumor;
- Child-Pugh A or B;
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- at least one measurable lesion according mRECIST;
- cannot afford sorafenib;
- the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin<3-times upper limit of normal; ALT<5-times upper limit of normal; AST<5-times upper limit of normal; serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3
- sign up consent;
- unrolled by other clinical trials about hepatocellular carcinoma.
Who cannot join
- cannot tolerate TACE;
- CNS or bone metastasis exits;
- known history of other malignancy;
- be allergic to related drugs;
- underwent organ transplantation before;
- be treated before (interferon included);
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- known history of HIV infection;
- known history of drug or alcohol abuse;
- have GI hemorrage or cardiac/brain vascular events within 30 days;
- pregnancy;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Center of Sun Yat-Sen University
Guangzhou, Guangdong, +86-20
Shaohua Li, MD, +8615088064187, lishaoh@sysucc.org.cn
About this study
The current random, double-blind, controlled, clinical trial was designed to evaluate the impact on therapeutic effect and tolerance of treatment for patients with hepatocelluclar carcinoma in transcatheter arterial chemoembolization (TACE) of dexamethasone application.
- Conditions
- HepatoCellular Carcinoma
- Being tested
- Dexamethasone, Normal Saline
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
use dexamethasone 10mg (2ml) I.A. during TACE
Normal SalineDrug
use normal saline 2ml I.A. during TACE
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | use dexamethasone 10mg (2ml) I.A. during TACE Receives: Drug: Dexamethasone |
| control group | Placebo comparator | use normal saline 2ml I.A. during TACE Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate (RR)
Measured: 1 month after TACE
proportions of participants with severe adverse events according to CTCAE v4.03
Measured: 1 month after TACE
Secondary outcomes (3)
overall survival (OS)
Measured: From date of randomization until the date of death from any cause, assessed up to 60 months
progression-free survival (PFS)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
time to progression (TTP)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatoCellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Shaohua, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987907
- Sponsor's protocol ID
- B2016-024-01
- Status last verified
- Dec 2016
- First submitted
- 1 Dec 2016
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact on Therapeutic Effect and Tolerance of Treatment for Patients With Hepatocellular Carcinoma in Transcatheter Arterial Chemoembolization (TACE) of Dexamethasone Application: A Random, Double-blind, Controlled, Clinical Trial.
- ClinicalTrials.gov ID
- NCT02987907
- Acronym / sponsor ID
- B2016-024-01
- Conditions
- HepatoCellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current random, double-blind, controlled, clinical trial was designed to evaluate the impact on therapeutic effect and tolerance of treatment for patients with hepatocelluclar carcinoma in transcatheter arterial chemoembolization (TACE) of dexamethasone application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Dexamethasoneuse dexamethasone 10mg (2ml) I.A. during TACE |
| control group | Placebo comparator | Drug: Normal Salineuse normal saline 2ml I.A. during TACE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- older than 18 years old;
- ECOG PS<3;
- proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
- meeting at least 1/4: 1) multiple nodules, 2) single tumor but not suitable for resection, 3) vascular invasion exists, 4) distant metastasis excluding CNS and bone
- not previous treated for tumor;
Key exclusion criteria (10 listed)
- cannot tolerate TACE;
- CNS or bone metastasis exits;
- known history of other malignancy;
- be allergic to related drugs;
- underwent organ transplantation before;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasoneuse dexamethasone 10mg (2ml) I.A. during TACE | Drug | treatment group |
| Normal Salineuse normal saline 2ml I.A. during TACE | Drug | control group |
Primary outcome
response rate (RR)
Time frame: 1 month after TACE
proportions of participants with severe adverse events according to CTCAE v4.03
Time frame: 1 month after TACE
3 secondary outcomes
overall survival (OS)
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
progression-free survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
time to progression (TTP)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone and Normal Saline in people with HepatoCellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaohua Li, MD (+8615088064187, lishaoh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (RR) (time frame: 1 month after TACE). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2016.